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Study on the Effects of Etrasimod Arginine for Patients with Moderate to Severe Crohn's Disease

Fast replyInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying Crohn's Disease, a condition that causes inflammation in the digestive tract, leading to symptoms like abdominal pain, severe diarrhea, fatigue, weight loss, and malnutrition. The study is testing a medication called Etrasimod Arginine, which is taken as a tablet. The purpose of the study is to evaluate the safety and effectiveness of this medication as a treatment for people with moderately to severely active Crohn's Disease.

Participants in the study will be randomly assigned to receive either the Etrasimod Arginine tablet or a placebo. The study is designed to be "double-blind," meaning neither the participants nor the researchers will know who is receiving the actual medication and who is receiving the placebo. This helps ensure that the results are not biased. The study will take place over a period of time, with regular check-ins to monitor the participants' health and the effects of the treatment.

The study aims to determine the best dose of Etrasimod Arginine for treating Crohn's Disease by comparing the effects of two different doses. Researchers will look at how well the medication works in reducing the symptoms of the disease and how safe it is for the participants. The ultimate goal is to find a dose that is both effective and safe for long-term use in managing Crohn's Disease.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as age, diagnosis of Crohn's disease, and previous treatment history.

    Written informed consent is required, and the ability to comply with the study schedule is assessed.

  2. Step 2

    Induction therapy

    The induction phase involves taking etrasimod arginine tablets orally. The dosage and frequency are determined by the study protocol.

    This phase aims to evaluate the initial response to the medication over a specified period, typically up to 14 weeks.

  3. Step 3

    Assessment of response

    During the induction phase, the response to treatment is assessed through clinical evaluations and endoscopic examinations.

    The primary goal is to observe any endoscopic response and clinical remission, which are key indicators of the medication's effectiveness.

  4. Step 4

    Maintenance therapy

    If the induction therapy is successful, the patient may continue to the maintenance phase, which involves ongoing administration of etrasimod arginine tablets.

    This phase is designed to maintain the therapeutic benefits achieved during induction and is evaluated over a longer period, potentially up to 52 weeks.

  5. Step 5

    Ongoing monitoring

    Throughout the trial, regular monitoring is conducted to ensure safety and track the progress of the treatment.

    This includes periodic clinical assessments, laboratory tests, and endoscopic evaluations to monitor the disease activity and any side effects.

  6. Step 6

    Completion of the trial

    Upon completion of the trial, a final assessment is conducted to evaluate the overall effectiveness and safety of the treatment.

    The results contribute to the understanding of etrasimod arginine as a potential therapy for Crohn's disease.

Who can join the trial?

7 criteria

  • Participants must be between 18 and 80 years old.
  • Participants must be able to provide written consent and follow the study schedule.
  • Participants must have been diagnosed with Crohn's Disease for at least 3 months, affecting the ileum (part of the small intestine) and/or colon (part of the large intestine). This diagnosis can be confirmed by past medical tests.
  • Participants must have moderately to severely active Crohn's Disease, which means a specific score on the Crohn's Disease Activity Index (CDAI) between 220 and 450, along with certain symptoms like abdominal pain or frequent loose stools, and a specific score on an endoscopic test called SES-CD.
  • Participants must have previously tried and not responded well, lost response, or could not tolerate at least one of the following treatments for Crohn's Disease: oral corticosteroids, immunosuppressants, TNFα antagonists, integrin receptor antagonists, or interleukin-12/23 antagonists.
  • Females who can become pregnant must not be pregnant.
  • Females who can become pregnant and males must agree to use contraception during the study.

Who cannot join the trial?

14 criteria

  • Patients who have other serious health conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have had a recent surgery or are planning to have surgery during the study period.
  • Patients who are currently participating in another clinical trial.
  • Patients who have a history of severe allergic reactions to medications.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have an active infection that requires treatment.
  • Patients who have been diagnosed with cancer in the past five years, except for certain types of skin cancer.
  • Patients who have a history of heart problems, such as heart attack or heart failure.
  • Patients who have uncontrolled high blood pressure.
  • Patients who have liver or kidney disease.
  • Patients who have a history of blood clotting disorders.
  • Patients who have a history of mental health disorders that are not well controlled.
  • Patients who are unable to follow the study procedures or attend study visits.
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Investigated drugs

Etrasimod is an oral medication being studied for its potential to help people with moderately to severely active Crohn's disease. The trial aims to evaluate how safe and effective etrasimod is when used as an initial treatment. The study also seeks to understand how different doses of etrasimod work in comparison to each other. The goal is to find the most effective and safe dose for further development.

What is already known about the treatment

Etrasimod – Etrasimod is administered orally and is currently being studied in clinical trials for its effectiveness and safety in treating moderately to severely active Crohn's Disease. It is not yet widely used in standard medical practice, as it is still under investigation. The main therapeutic indication for etrasimod is Crohn's Disease, a chronic inflammatory condition of the gastrointestinal tract. At the molecular level, etrasimod works by modulating the immune system, specifically targeting the sphingosine 1-phosphate (S1P) receptor, which plays a role in lymphocyte movement and inflammation. It is classified pharmacologically as an S1P receptor modulator.

Investigated diseases

Crohn's Disease – Crohn's Disease is a chronic inflammatory condition of the gastrointestinal tract, primarily affecting the small intestine and colon. It is characterized by periods of flare-ups and remission, where symptoms can vary in intensity. During flare-ups, individuals may experience abdominal pain, diarrhea, fatigue, and weight loss. The inflammation can penetrate deep into the layers of the bowel tissue, leading to complications such as strictures or fistulas. The exact cause of Crohn's Disease is unknown, but it is believed to involve a combination of genetic, environmental, and immune system factors. The progression of the disease can vary greatly among individuals, with some experiencing mild symptoms and others facing more severe challenges.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2024-513569-38-00Protocol codeC5041006Estimated enrolment1 175 patientsSponsorArena Pharmaceuticals Inc.

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).